Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced the appointment of Brian M. Johnson as its Chief
Commercial Officer. Additionally, the Company received notice that
the U.S. Food and Drug Administration (FDA) has conditionally
accepted KINSOLUS™ as the brand name for SB206, a topical antiviral
gel for the treatment of molluscum contagiosum (a viral skin
infection), if approved.
Mr. Johnson is a well-established executive with
more than three decades of commercialization experience in leading
products to dominant market positions across multiple therapeutic
areas. He has a successful track record of implementing commercial
strategy and message development through tactical planning and
execution at dermatology companies including Ortho Pharmaceutical
Corporation, Medicis, and Galderma. From 2015 to 2018, Mr. Johnson
served as Chief Commercial Officer of Novan, where he led the
Company’s pre-commercial activities including the assessment of the
molluscum contagiosum market opportunity and the acne market sizing
and segmentation project.
“We are pleased to welcome back Brian as our
Chief Commercial Officer. His intimate knowledge of Novan and
expertise in dermatology position him to be the best suited
individual to lead our pre-launch and commercialization efforts as
we advance SB206. Brian’s appointment is a key component as we
build our internal infrastructure to interface with our commercial
solutions provider, Syneos Health, and advance SB206 toward
potential commercialization,” commented Paula Brown Stafford,
President and Chief Executive Officer. “I am also pleased the FDA
has conditionally accepted KINSOLUS™ as the brand name for SB206.
In planning for success, this represents an important step in our
pre-commercial activities and brings us closer to being able to
potentially offer an effective treatment to patients in a condition
with no current FDA approved therapeutic option. We believe there
is significant commercial potential within our development
pipeline, and we are pleased with the progress we continue to
make.”
Mr. Johnson joins Novan having most recently
served as a Principal at Two Hearts Group, a pharmaceutical and
life science consulting firm. While at Two Hearts he acted as UCB’s
Head, Digital Marketing, Psoriasis in the Global Mission for
bimikizumab. Notably, at Galderma he served as Vice President of
Prescription Marketing and Chief Digital Officer. While there, he
and his team successfully launched seven products and quadrupled
sales from $275 million to over $1 billion led by Epiduo®, Clobex®
and Oracea®. Other career appointments of note are President,
Revian, Inc and Director, Peer to Peer Marketing at Novartis. Mr.
Johnson holds an MBA from Southern Methodist University and a BS in
Business Administration from the University of Kansas. He is a
member American Acne and Rosacea Society, Masters of Dermatologic
Society, Women’s Dermatology Society and the American Academy of
Dermatology.
“Novan’s NITRICIL™ technology and the ability to
apply it in so many areas across dermatology is an exciting
opportunity with vast possibilities to address areas of significant
unmet medical need. In the years since having last worked with
Novan, I continued to work in dermatology gaining even more
valuable knowledge and experience that I believe well-positions me
to successfully complete what I consider the unfinished business I
began years ago. Based on the results the Novan team has generated,
I believe SB206, if approved, not only has significant potential to
provide patients with a much-needed treatment benefit, but also
serve as a solid foundation from which the Company can grow and
build value across the dermatology space,” added Mr. Johnson. “With
the work to build a successful, commercial-stage company now
underway, I look forward to completing the business of helping
unlock Novan’s full potential.”
The name KINSOLUS™ (pronounced “Kin-SOL-us”) was
developed in compliance with FDA’s Guidance for Industry, Contents
of a Complete Submission for the Evaluation of Proprietary Names. A
request for proprietary name review and final approval for
KINSOLUS™ will be included when Novan submits its NDA for
SB206.
About Novan
Novan, Inc. is a pre-commercial nitric
oxide-based pharmaceutical company focused on dermatology and
anti-infective therapies. We leverage our core synergies of
science, capital, resources and patient needs to create value by
bringing new nitric oxide-based medicines to market. Our goal is to
create the world’s leader in nitric oxide-based science,
technology, and clinical translation in support of delivering safe
and efficacious therapies using our proprietary nitric oxide-based
technology platform, NITRICIL™ to generate macromolecular New
Chemical Entities (NCEs) to treat multiple indications.
About
KINSOLUS™ (SB206)
Berdazimer, the active ingredient in KINSOLUS
(SB206), is a new chemical entity that stores nitric oxide gas in a
stable, solid form by chemically loading it on a macromolecule, or
polymer. Nitric oxide is released in a targeted manner to kill
microbial pathogens, including bacteria, fungi and viruses. The
topical semi-solid formulation of SB206 tunes the release of
berdazimer in a solid form on demand specific to disease. SB206 is
being developed as a topical anti-viral gel for the treatment of
viral skin infections, with a current focus on molluscum
contagiosum.
About Molluscum Contagiosum
Molluscum is a common, contagious skin infection
caused by the molluscipoxvirus, affecting millions of people in the
U.S. annually, with the greatest incidence in children.
Approximately 70% of patients are below the age of 10. There are
currently no U.S. FDA approved therapies for the treatment of
molluscum. More than half of patients diagnosed with the infection
are untreated.
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe,” “expect,” “target,”
“anticipate,” “may,” “plan,” “potential,” “will,” and similar
expressions, and are based on the Company’s current beliefs and
expectations. These forward-looking statements include, but are not
limited to, statements related to the potential therapeutic value
of the Company’s NITRICIL™ platform technology, the Company’s
pharmaceutical development of nitric oxide-releasing product
candidates, the potential timing of clinical trials, stability
testing and FDA submission(s), and that conditional proprietary
brand name approval will support the Company’s commercialization
strategy, if KINSOLUS™ is approved;. Forward-looking statements are
subject to a number of risks and uncertainties that could cause
actual results to differ materially from the Company’s
expectations, including, but not limited to, risks related to the
regulatory approval process, which is lengthy, time-consuming and
inherently unpredictable, including the risk that the FDA will not
agree with the Company’s approach to a potential NDA submission,
that the Company’s product candidates may not be approved or that
additional studies may be required for approval or other delays may
occur, that the FDA may not give final approval of the KINSOLUS™
brand name; that the Company may not have sufficient quantities of
drug substance and/or drug product to support regulatory
submissions and that the Company may not obtain funding sufficient
to complete the regulatory or development process; the Company’s
limited experience as a company in obtaining regulatory approvals
and commercializing pharmaceutical products; changes in the size
and nature of the market for our product candidates, including
potential competition; any operational or other disruptions as a
result of the COVID-19 pandemic; the Company’s ability to obtain
additional funding or enter into strategic or other business
relationships necessary or useful for the further development or
commercialization of the Company’s product candidates; risks
related to the manufacture of raw materials, including the
Company’s active pharmaceutical ingredient and drug product
components utilized in clinical trial materials, including supply
chain disruptions or delays, failure to transfer technology and
processes to third parties effectively or failure of those third
parties (or the Company in connection with the upfit of the
Company’s new facility) to obtain approval of and maintain
compliance with the FDA or comparable regulatory authorities; the
Company’s reliance on arrangements with third parties to support
its operations and development efforts and the risk that such
parties will not successfully carry out their contractual duties or
meet expected deadlines; and other risks and uncertainties
described in the Company’s annual report filed with the Securities
and Exchange Commission on Form 10-K for the twelve months ended
December 31, 2020, and in the Company’s subsequent filings with the
Securities and Exchange Commission. Such forward-looking statements
speak only as of the date of this press release, and Novan
disclaims any intent or obligation to update these forward-looking
statements to reflect events or circumstances after the date of
such statements, except as may be required by law.
INVESTOR AND MEDIA
CONTACT:Jenene Thomas JTC Team,
LLC833-475-8247NOVN@jtcir.com
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